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4-point vs 4-roll Canne as Walking Aids After Stroke (4roll)

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ClinicalTrials.gov Identifier: NCT02279069
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Deltombe Thierry, University Hospital of Mont-Godinne

Brief Summary:

Stroke patients frequently necessitate walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.

The aim of our study is to compare gait parameters (gait speed and energy cost) with a classical 4-point canne and with 4-roll canne.


Condition or disease Intervention/treatment Phase
Stroke Device: 4-roll canne Not Applicable

Detailed Description:

Stroke patients frequently need walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.

OBJECTIVE To compare the gait parameters with a 4-point canne and with a 4-roll canne METHODS The investigators will recruited stroke patients who necessitate 4 point-canne as walking aids. A 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne (day 2) in a cross-over study. The first tested device will be randomized.

PERSPECTIVE The investigators hope to demonstrate that a 4-roll canne makes possible to walk faster in a safe way after stroke


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Classical 4-point Canne and 4-roll Canne on Gait Parameters (Gait Speed and Energy Cost) as Walking Aids After Stroke. A Multicentric Randomized Controled Cross-over Study
Study Start Date : October 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: 4-point canne
Stroke patients walk with 4-point canne
Device: 4-roll canne
Experimental: 4-roll canne
Stroke patients walk with 4-roll canne
Device: 4-roll canne



Primary Outcome Measures :
  1. 10 meters walking test at spontaneous speed [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. 10 meters walking test at fast speed [ Time Frame: 2 days ]
  2. 6 minutes walking test [ Time Frame: 2 days ]
  3. Borg scale for perceived exertion [ Time Frame: 2 days ]
  4. Visual analogic scale for personal satisfaction [ Time Frame: 2 days ]
  5. Energy cost [ Time Frame: 2 days ]
    Extrapolated from heart rate while walking



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post stroke patient
  • able to walk 10 meters

Exclusion Criteria:

  • cognitive impairment limiting walking capacities
  • need support when walking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279069


Locations
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Belgium
Deltombe Thierry
Yvoir, Belgium, 5530
Sponsors and Collaborators
University Hospital of Mont-Godinne
Investigators
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Principal Investigator: Thierry Deltombe, MD CHU Dinant Godinne / UcL Namur
Principal Investigator: Geoffroy Dellicour, PT Centre Neurologique William Lennox Ottignies

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Responsible Party: Deltombe Thierry, Professeur Clinique, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT02279069     History of Changes
Other Study ID Numbers: MG-4roll-53/2014
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Keywords provided by Deltombe Thierry, University Hospital of Mont-Godinne:
stroke
walking
rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases